Tag: clinical research

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.

In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

Process Design

Process Qualification

Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.

The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.

The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.

Thorough understanding of how to implement Applied Statistics for FDA Process Validation

The ways of using Applied Statistics for FDA Process Validation will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. At this seminar, Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director.

The focus of this two-day course on Applied Statistics for FDA Process Validation is the various ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Dr. Burdick will begin with a primer on statistics, where he will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.

The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Since the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

The aim of this learning on Applied Statistics for FDA Process Validation is to lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

Complete learning on Applied Statistics for FDA Process Validation

Over the two days of this seminar, the participants will learn how to:

Apply statistics for setting specifications

Assess measurement systems (assays)

Use Design of Experiments (DOE)

Develop a control plan as part of a risk management strategy, and

Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

Apply statistics to set specifications and validate measurement systems (assays)

Develop appropriate sample plans based on confidence and power

Implement suitable statistical methods into a process validation program for each of the three stages

Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.

He is the second person to die from flesh-eating bacteria since Hurricane Harvey struck the Gulf Coast. Two weeks ago, a 77 year old woman died after a fall inside her flooded home in which she cut her arm and subsequently contracted the flesh-eating bacteria.

When the man initially presented to the hospital on October 10th, officials described an infected wound affecting the upper portion of his left arm.

A cut, scrape, puncture or any break in the skin may serve as a portal of entry for the dangerous bacteria, which then leads to destruction of blood vessels, fat, nerves and a white fibrous covering of the muscle known as the fascia. The infection then proceeds to enter the muscle, compromising blood flow and leading to death of the tissue.

Its important to realize that bacteria don’t actually digest the tissue, but instead produce a deadly toxin that is responsible for the extensive tissue damage.

As the bacteria enter the bloodstream, fever, chills and vomiting may rapidly develop, leading to a dangerous condition known as sepsis which is characterized by low blood pressure, rapid and difficult breathing and confusion.

Necrotizing fasciitis is a surgical emergency. Aggressive fluid resuscitation along with broad spectrum antibiotics must be started promptly with emergent preparation for surgery to remove or debride the affected area in order to contain the infection.

Persons with diabetes, chronic kidney disease and cancer who are receiving chemotherapy are most at risk for complications, due to poor blood supply to skin, muscle and soft tissue from having such chronic conditions.

Flood waters harboring bacteria (from sewage), along with dirty surfaces or debris contacting the victim’s initial cut or injury, likely led to the onset of this aggressive and deadly infection. As a general rule, it’s best to keep all cuts or blisters covered with a dry gauze and waterproof type dressing if there is any potential to come in contact with floodwater or dirty surfaces or debris.

The CDC describes about 700-1,110 cases annually in the U.S., the result of an active surveillance and reporting network that is set up to monitor such aggressive infections.

Cases of typhoid and cholera, invasive and aggressive diarrheal illnesses typically associated with floods in developing countries, never materialized after the hurricane, according to data from the CDC. In addition, cases of tetanus, which can develop from heavily contaminated wounds after soil exposure, have generally not been a concern with such flooding in the U.S., as supported by data from the CDC.

“Necrotizing fasciitis is caused by strep group A (flesh-eating bacteria) or anaerobic bacteria which thrive in areas without oxygen,” said Debra Spicehandler, MD, Co-Chief of Infectious Diseases, Northern Westchester Hospital. ”Antibiotics are important but swift surgical debridement is necessary. The cases caused by strep release a toxin which can also cause systemic effects and organ failure leading to mortality.”

How does a global airline like Emirates cater to the needs of its over 55 million customers? Here’s a neat infographic that gives you a glimpse into how Dubai’s flagship airline is able to meet and exceed its customer’s gastronomic requirements!

Emirates serves more than 100 million meals a year with the same attention to detail in First, Business and Economy Class. Catering for more than 55 million dine-in guests a year travelling to and from 144 cities across 6 continents, no one understands global culinary trends better than Emirates as it serves destination-inspired cuisine onboard the world’s largest flying restaurant.

With a catering investment of US$1 billion per year, Emirates runs a round-the-clock kitchen with 1,200 chefs based in Dubai whipping up 12,450 recipes. The finely-tuned operation caters 590 flights a day with authentic local cuisines giving customers a taste of the destination they are going to. The airline also works closely with 25 catering partners around the world to provide the same quality of food for its Dubai-bound flights.

Infographic: Emirate Airline – Catering to the World

Catering to the world. Infographic courtesy-Emirates

Global delicacies local flavour

Emirates’ focus on local flavour means it has food available from every region it flies to. Flights to Japan for example, offer authentic Kaiseki cuisine and Bento boxes served with Japanese crockery, cutlery and tea sets to ensure an unrivalled food experience on board.

The airline recently launched a new menu for its Australian routes inspired by the breadth of the country’s multicultural flavours and cuisines, after a 14-month process working in consultation with local chefs.

The new menu features a broad range of traditional local favourites such as minted lamb sausages. Reflecting Australia’s multiculturalism, the menu also includes Asian flavours, as well as Middle Eastern flavours and ingredients, catering to Emirates’ diverse passenger mix and representing its global route network.

To keep up with regional and seasonal food trends, Emirates changes its onboard menus monthly and continually reviews its recipes.

The varied menus on each route are also reflected in the bread baskets served on board. Flavoured breads or breads produced with a sourdough base are popular on European routes while parathas, pooris, and naan bread are served on all nine Emirates routes to India. On its Middle Eastern routes, customers get to enjoy Arabic bread – Markook – a very thin unleavened bread common in the region, and Manakesh which is either topped with Zaatar or Cheese.

In premium classes, meals are served on Royal Doulton tableware with Robert Welch cutlery specially designed for Emirates.

Global partners, best of local and artisanal produce

Emirates focuses on simple, well cooked dishes that emphasise fresh ingredients of the highest quality. The airline brings the finest products on board through long standing partnerships worldwide, and supporting local suppliers and artisans. This includes sourcing over 15,000 kilograms of Persian feta from the Yarra Valley in Australia each year. The olive oil served on board is exclusively from carbon neutral producer Monte Vibiano in Italy, a partnership that is now more than 15 years old.

Today, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example is a practice known as “step therapy” or “fail first.”

Now, when patients visit their doctors for a prescription, the treatments they are prescribed are typically based on a variety of personal factors. These factors include their health history, underlying symptoms, and their doctor’s long-term understanding of their condition, such as whether they have already tried certain drugs under a different health insurance plan, if they have other medical conditions that might interfere with the drug’s effect, whether certain drug’s side effects will affect the patient’s ability to perform their job, or if the patient would prefer a drug that has a different ingestion method or dosage form. Treatment plans need to be based on the individual’s needs, and their doctors’ medical expertise and first-hand knowledge of their patients’ overall health.

However, far too often, what happens next is the problem. When a patient goes to the pharmacy to fill their prescription, they may be informed that their physician-prescribed medicine will not be covered unless the patient first proves that another medication-one of the insurer’s choosing, not their doctor-will not work for them.

In such a case as this, failure is not only an option, it is the only option before getting appropriate treatment.

Under the current system, patients are left with a limited set of options: either try a medication that is not what their doctor recommended for their condition, or pay out of pocket for the treatment they need. For many people, that’s not a choice at all. They are simply forced to fail on a medication other than what their doctor prescribed.

Dear Doctor: My daughter, who is in her 40s, has fibromyalgia. Is there any cure for this painful condition, or any natural remedies? I hate to see her suffer.

Dear Reader: The word “suffer” perfectly sums up fibromyalgia, and my heart goes out both to your daughter and to you, who can see the condition’s terrible effect on her. A chronic pain disorder initially termed “fibrositis syndrome” in the mid-19th century, fibromyalgia has been an official diagnosis only since 1990. The condition causes widespread musculoskeletal pain and fatigue, as well as sleep problems and difficulties in concentration and with memory.

In the United States, 2 to 3 percent of the population suffers from fibromyalgia, with women affected twice as often as men. Blood tests can’t detect fibromyalgia, so the diagnosis is based on a person’s symptoms, including the tender points identified during a physical examination. That said, people with fibromyalgia have shown abnormal biochemical responses to painful stimuli, and those responses can help guide treatment.

The first step in treating fibromyalgia is to understand the illness and what triggers a flair of symptoms. Anxiety and depression are common with fibromyalgia, and the resulting emotional stress can create a cycle of worsening pain and even lower energy levels.

Let’s take a look first at non-medical interventions. Practicing good sleep hygiene is vital because poor sleep can worsen fibromyalgia pain and fatigue, and trigger the cycle mentioned above. Relaxation techniques and therapy can relieve anxiety and depression, while meditation training can ease pain. Further, reflexology and acupuncture have each shown benefits in small studies at easing a variety of symptoms.

Exercise is a crucial component of therapy. Multiple studies have shown that it decreases pain, increases flexibility and boosts energy. Note that if exercise is too vigorous or of high impact, it may cause a flair of symptoms. The key is to start slowly with low-impact exercise, such as walking, biking, swimming or water aerobics. As symptoms improve, patients can increase their level of exercise.

Although they don’t cure the illness, various drugs and supplements can improve specific symptoms.

A 35-year-old man who had been in a vegetative state for 15 years is showing signs of consciousness after receiving a pioneering treatment based on nerve stimulation.

In the month since a vagus nerve stimulator was put into his chest, the man, who was injured in a car accident, has begun responding to simple orders that had been impossible before.

The findings reported in Current Biology may help to show that by stimulating the vagus nerve “it is possible to improve a patient’s presence in the world”, according to lead researcher Angela Sirigu of Institut des Sciences Cognitives Marc Jeannerod in Lyon, France.

The researchers say it may challenge the view that a vegetative state which lasts for more than 12 months is irreversible.

“Other scientists have hailed it as “a potentially very exciting finding” but have also urged caution.

After treatment, it was reported the patient could follow an object with his eyes, turn his head on request and his mother said there was an improved ability to stay awake when listening to his therapist reading a book.

The vagus nerve connects the brain to many other parts of the body, including the gut.

It is known to be important in waking, alertness, and many other essential functions.

The patient, who was picked because he had been lying in a vegetative state for more than a decade with no sign of improvement, also appeared to react to a “threat”.

Researchers spotted that he reacted with surprise by opening his eyes wide when the examiner’s head suddenly approached his face.